UMIN-CTR Clinical Trial

Public title

Effects of exercise training in peritoneal dialysis patients

Acronym

Exercise training in peritoneal dialysis patients

Scientific Title

Effects of exercise training in peritoneal dialysis patients

Scientific Title:Acronym

Exercise training in peritoneal dialysis patients

Region

Japan

Condition

Peritoneal dialysis patients

Classification by specialty

Endocrinology and Metabolism	Nephrology	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effects of 12-week home-based exercise training in peritoneal dialysis patients. Primary endpoint includes aerobic capacity and quality of life, and secondary endpoint includes parameters such as muscle strength, residual renal function, cholesterol, arterial stiffness.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Exercise capacity assessed by shuttle walking test and quality of life, evaluated 12 weeks after assignment

Key secondary outcomes

Parameters including muscle strength,residual renal function, cholesterol, arterial stiffness, evaluated 12 weeks after assignment

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Twelve-week home-based exercise training, including 20-30 minutes of aerobic exercise thrice-weekly and resistance training twice-weekly. Exercise intensity is determined by the result of shuttle walking test and major muscle testing at baseline. Aerobic exercise and resistance training are performed with the target of 40-60% of the peak oxygen uptake (VO2peak) and 70% of 1 repetition maximum (RM), respectively.

Interventions/Control_2

No treatment

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Peritoneal dialysis outpatients.
2) Patients from whom written informed consent was obtained.

Key exclusion criteria

1) Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases.

2) Unstable PD patients. Concrete criteria are as follows: patients who undergo PD less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L).

3) Patients deemed inadequate for monitoring during study period, as determined by investigators.

Target sample size

48

Name of lead principal investigator

1st name
Middle name
Last name	Shu Wakino

Organization

Department of internal medicine, Keio University, School of Medicine

Division name

Division of Endocrinology, Metabolism and Nephrology

Zip code

Address

35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan

TEL

+81-3-3353-1211(-0535)

Email

shuwakino@z8.keio.jp

Name of contact person

1st name
Middle name
Last name	Kiyotaka Uchiyama

Organization

Department of internal medicine, Keio University, School of Medicine

Division name

Division of Endocrinology, Metabolism and Nephrology

Zip code

Address

35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan

TEL

+81-3-3353-1211(-0588)

Homepage URL

Email

kiyo.0817.piyo@keio.jp

Institute

Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine Keio University, School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

11

Month

18

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

01

Day

Last follow-up date

2018

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

19

Day

Last modified on

2018

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027068